Ra Officer

2 weeks ago

Daman and Diu, India Quality HR Services Full time

Opening: 1 Nos.- Job ID: 53769- Employment Type: Full Time- Reference:
- Work Experience: 1.0 Year(s) To 7.0 Year(s)- CTC Salary: 3.00 LPA TO 5.00 LPA- Function: Pharma / Biotech / Healthcare / Medical / R&D- Industry: Pharma/Biotech/Clinical Research- Qualification: B.Pharma - Pharmacy; M.Pharma - Pharmacy- Location:

- Daman - Diu

Posted On: 23rd Jan, 2023
**Position: RA Officer

Location: Daman

Experience: 1- 7 Years

Industries: Pharma

**Responsibilities**:

- Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities
- Coordinate with various departments to collect the complete set of documents.
- Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, batch records, stability, finished product /packaging material data for the purpose of compilation of dossier.
- Review of documents required for regulatory agencies (Viz DMF, analytical reports, process validation reports, PVP, PDR, protocols & stability data)
- Preparation of various pharmacological, preclinical and toxicological data based on published literature
- Submission of the notification to regulatory agency for the post approval changes.
- Preparation of SPC, package insert and labeling information.
- Review of vendor documents as a part of vendor qualification programmer and to communicate with supplier & manufacturer of the API & Excipients for the related vendor documents
- Preparation of template of the vendor quality Agreement and to communicate with the vendor for its final execution
- Any other work assigned by management within the scope of regulatory framework.

**Required Qualification**: - **B.Pharm/M.Pharm**

**Salary**:

- **Upto 5.00 LPA**

**If you are interested for this opening please send updated resume **on same mail with following details**.**

Total No. of Years Experience:

- Current CTC:

- Expected CTC:

- Notice Period:

- **Thanks,**

**Quality HR Services**

**Key Skills**:

- Ra
- Drug Regulatory Affair
- Ra Officer

**Company Profile**:
One of the reputed US FDA approved Pharma formulation Company.

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